# K240725: PreXolid CAD/CAM abutments

- Pathway: 510(k) (Traditional)
- Applicant: Eclectic Co., Ltd.
- Decided: Oct 18, 2024 after 214 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K894844 (1990). 172 ancestors in all.
No later device cites it as a predicate yet.
0 of 173 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220562: TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment, Megagen Implant Co., Ltd. (2022) Summary page 5.

## Indications for use
PreXolid CAD/CAM Abutments are intended for use on endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in the prosthetic rehabilitation. Compatible Implant System Implant Body Diameter, mm Implant Platform Diameter, mm XPEED AnyRidge Internal Implant System, Standard Type 5.0,5.5 3:3 XPEED AnyRidge Internal Implant System, Standard Type 5.0,5.5,6.0 4.0 XPEED AnyRidge Internal Implant System, Standard Type 6.0,6.5,7.0,7.5, 8.0 4.8 For PreXolid CAD/CAM Abutments, all digitally designed abutments for use with PreXolid CAD/CAM Abutments are intended to be sent to an Eclectic-validated milling center for manufacture.

Source page: https://510kreport.com/device/K240725
Methodology: https://510kreport.com/methodology